InterMune shares more than double on tests for lung-disease treatment

Shares of InterMune Inc. more than doubled in early trading Tuesday after the biotech company reported positive Phase 3 test results for a drug used to treat an often fatal lung disease that was once rejected by federal regulators.

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InterMune
/quotes/zigman/85637/delayed/quotes/nls/itmnITMN soared by more than 132% to $32.46 in recent action. The company says it will resubmit the drug, generically known as pirfenidone, for approval by the U.S. Food and Drug Administration.

The FDA rejected InterMune’s application to use the drug to treat idiopathic pulmonary fibrosis, or IPF, a progressive decline in lung function, in 2010. The agency said at the time it wanted to see further trials of the drug.

The company says it now will resubmit the drug for FDA approval early in the third quarter. InterMune already has won approval in Europe and Canada for the drug, where it is marketed as Esbriet. Esbriet is expected to remain the trade name in the U.S. Pirfenidone is sold as Pirespa in Japan and South Korea, and is approved for treatment of IPF in China, India, Argentina and Mexico.

InterMune says the tests showed a 47.9% reduction in the proportion of patients who experienced more than a 10% drop in lung capacity or death from the disease. Further, the proportion of patients that experienced no dropoff in lung capacity was 22.7%, more than double the 9.7% of those who weren’t using the drug.

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